PSUR Safety Report Compiler
Automate PSUR assembly with ICH-compliant safety data synthesis and signal detection
What You Can Do
You can accelerate PSUR compilation by transforming raw safety databases into regulatory-grade narratives with complete traceability. The skill structures your workflow to organize adverse event data hierarchically, identify emerging safety signals, assess causality patterns, and integrate findings with existing Risk Minimization Action Plans. You'll reduce manual compilation time by hours while ensuring your reports meet strict ICH formatting requirements and regulatory standards across multiple jurisdictions.
Features
Aggregate and organize safety data from multiple sources into structured PSUR sections with automated counting and classification
Identify unexpected adverse event patterns and escalation triggers using statistical comparison against baseline incidence
Ensure report structure, formatting, and narrative comply with current regulatory guidance for FDA, EMA, and Health Canada submissions
Systematically evaluate adverse event causality using standardized assessment algorithms (Naranjo, WHO-UMC) with documented reasoning
Link PSUR findings to current RMAPs and update risk-benefit assessments based on new safety data
Generate harmonized core PSUR data with jurisdiction-specific formatting and submission requirements
Cross-check adverse event counts, seriousness classifications, and causality determinations against source documentation for audit readiness
Create audit trails linking PSUR conclusions to source data with references for regulatory inspection preparation
Example Output
Example 1: Safety Signal Detection Summary
Reported Adverse Event: Elevated liver enzyme levels (ALT/AST)
- Case Count: 8 cases identified during reporting period (Q3 2024)
- Baseline Incidence: 0.2% in pre-marketing studies
- Current Incidence: 1.1% in post-market cohort (n=720 patients)
- Statistical Signal: Yes — exceeds 5× baseline threshold
- Causality Assessment: Probable in 6 cases, Possible in 2 cases
- RMAP Update: Recommend enhanced hepatic monitoring in product labeling
Example 2: PSUR Section 2.3.1 (Safety Specification)
The safety specification for [Product Name] has been updated to reflect new safety findings identified during the reporting period. No unexpected adverse event patterns were identified. The known safety profile remains consistent with previous PSURs, with the exception of elevated hepatic enzyme elevation noted above (see Section 3.2). All serious adverse events (n=12) were assessed for causality; 8 were classified as related, 4 as unrelated.
Example 3: Data Reconciliation Table
| Data Element | Database Count | Medical Review Count | Discrepancy | Resolution |
|---|---|---|---|---|
| Total AE Reports | 147 | 147 | None | ✓ Confirmed |
| Serious AEs | 12 | 12 | None | ✓ Confirmed |
| Fatal Outcomes | 2 | 2 | None | ✓ Confirmed |
| Drug-Related | 89 | 87 | 2 cases | Reviewed; reclassified unrelated |
What's Included
- PSUR-safety-report-compiler.md: Core skill instruction file with workflow orchestration and ICH compliance rules
- PSUR Assembly Checklist: Step-by-step validation checklist for each PSUR section (overview, safety updates, signals, risk-benefit)
- Safety Signal Assessment Template: Structured format for documenting signal investigations including case listings, causality evaluation, and recommendations
- ICH E2A/E2C(R2) Section Map: Regulatory requirement cross-reference guide mapping content requirements to submission jurisdiction (FDA, EMA, Health Canada)
- Data Reconciliation Worksheet: Audit-ready template for cross-checking adverse event counts, classifications, and causality determinations against source documents
- Risk Minimization Action Plan Integration Template: Framework for linking PSUR findings to existing or updated RMAPs with evidence justification
Who It's For
- Pharmacovigilance specialists managing post-market safety reporting for pharmaceutical products
- Regulatory affairs professionals preparing periodic safety updates for FDA, EMA, and international submissions
- Clinical safety scientists synthesizing adverse event data and conducting signal evaluation for RMP/RiskMAP updates
- Medical writers compiling PSUR narratives with regulatory compliance and traceability requirements
- Quality and compliance teams ensuring audit readiness and data integrity in pharmacovigilance documentation
Best For
- Routine PSUR cycles — Compiling safety data for annual, biennial, or IND-required reporting periods
- Safety signal evaluation — Systematically assessing unexpected adverse events and causality patterns for escalation
- Multi-country submissions — Preparing region-specific PSUR annexes with harmonized core safety data
- Post-marketing surveillance integration — Consolidating spontaneous reports, trial data, and literature findings into cohesive regulatory narratives
- Expedited safety reviews — Rapid PSUR assembly when signal investigations require urgent reporting to authorities
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